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ICMR guidelines on how to Diagnose, Stage and Evaluate workup for breast cancer

ICMR guidelines on how to Diagnose, Stage and Evaluate workup for breast cancer

Breast cancer is prone to systemic spread, the probability of which increases with tumour size, local infiltration and lymph node metastasis. Some investigations are essential for clinical management, especially if the desirable investigations are not feasible due to various reasons and indicated against each investigation for different stages of the disease.It is important for all the doctors to know the basic diagnosing protocol of the disease keeping in mind the high prevalence of the same in Indian Women

In 2016, Indian Council Of Medical Research, ICMR issued guidelines/ Consensus document on Diagnosis, Staging and Evaluating Work up of Breast Cancer. Following are its major recommendations for the Management of the disease.

          OBC LOBC/LABC MBC  Purpose/ Comments
 RoutineTests (CBC, Biochemistry)  YES  YES   YES  To assess fitness for anesthesia & chemotherapy
 Breast Imaging (see flow chart)  Yes  Yes  *In selected cases where it is clinically indicated  B/LMammography: If the breast lump is suspected to be malignant, especially if BCT is being considered. USG: If cystic/ benign lesion is suspected, especially in young women MRI: In expert centres breast MRI is useful in screening or characterizing breast lump if mammography is sub-optimal due to dense breast (as in some young women) or prior breast reconstruction. Specially useful for screening young women at high risk of developing breast cancer due to family history or BRCA mutation
Cytological/ Histopathological Confirmation of diagnosis Yes  Yes Yes Core biopsy: Preferred method in all cases and mandatory if Neo- adjuvant systemic therapy is planned for histological grading and receptor status. To mark the site of the primary tumor the core biopsy should be centered over the tumor. FNAC: is acceptable in cases with clinical and mammographically evident cancer planned for upfront surgery. Incision or Excision Biopsy: When there is high clinical suspicion and repeated FNAC/core biopsy are negative
ER/ PR  Yes Yes Yes IHC (>1% tumour cells staining for ER considered ER+ve)16
 HER2  #YES  #YES  #YES  #More relevant in cases for whom Traztuzamab is feasible Standardized IHC for HER2; If IHC is equivocal (2+) then FISH
 ChestX Ray  Yes  Yes  Yes  To assess fitness for anesthesia and for staging in LOBC / LABC
 17BoneScan  *No  ^YES  ^YES  *If raised Alkaline Phosphatase or bone symptoms/sign ^If Bone scan not feasible due to various logistical or healthcare provision issues, perform Skeletal survey, especially if symptomatic.
 17USGAbdomen  *No  *If abnormal LFT or suspicious symptoms / signs. ^Not required if CT Thorax & Abdomen is being performed
 17CTThorax /Abdomen  *No  ^YES  ^YES  *If abnormal LFT or suspicious symptoms / signs. ^If CT Scan is not feasible due to various logistical or healthcare provision issues, Chest X Ray and USG Abdomen for staging
FDG PET/CT Scan No #In selected cases #In selected cases #Specially useful if standard imaging findings are equivocal.
Tumour markers (CA-15.3 etc No No No Clinical Utility in making diagnosis and disease monitoring not yet established
Multi-gene Signature Mammaprint and Oncotype Dx *No Notapplicable Not applicable Their clinical utility and added value in routine practice is as yet unknown and there is very little data in the Indian patients. Recently an IHC4 test (ER,PR, HER2 and Ki-67) seems to provide useful information and is advocated by NICE in research settings



All women with a breast lump should undergo a TRIPLE TEST comprising of

1. Clinical Examination by experienced clinician, preferably a breast surgeon.

2. Breast Imaging#: Bilateral Mammogram and or Ultrasound or MRI as appropriate.

3. Histopathology*: FNAC / Core biopsy (Ideal). Excision Biopsy/Incision biopsy if indicated.

Based on clinical examination and appropriate breast imaging the lump can be classified as cystic or solid. Based on the index of suspicion for malignancy (age, clinical finding, family history or previous breast biopsy findings) solid lesions can be further characterized as likely benign or suspicious for cancer. This will be the basis of their further evaluation as described below:

A) CYSTIC18,19: Breast Ultrasound followed by clinically guided or USG guided cyst aspiration. Women with small multiple cysts or if there is clear fluid on aspiration can be observed. Cytology / histopathology evaluation* is advised for cysts which are complex or hemorrhagic, refill rapidly or have a residual lump.

B) SOLID BENIGN: Should be evaluated with breast imaging# and excision biopsy if solid

C) SUSPICIOUS SOLID: Should be evaluated with breast imaging# and if on imaging the lump is still suspicious it should be evaluated with cytology / histopathology*

BENIGN: Excision biopsy

MALIGNANT: Follow relevant algorithm


1. If clinically it is a cyst: evaluate by USG.

2. If less than 30yrs and clinically benign: evaluate by USG.

3. If above 30 yrs or below 30 yrs with clinical suspicion: evaluate by Mammography+/-USG.

4. While there is no defined role of routine breast MRI prior to Breast Conserving surgery20, in centres with experience in Breast MRI, it may be used in women with

a. Premenopausal women with dense breasts & equivocal mammogram if BCT is planned.

b. Screening high risk women due to family history or BRCA mutation8 .

c. Axillary node metastasis without clinical/mammographic evidence of breast primary.

d. Optimal mammographic evaluation is not possible due to breast reconstruction or implants.


1. Core biopsy is preferred for all cases, especially if Neoadjuvant chemotherapy is planned (for grading and receptor status) and for guided biopsy of non-palpable lesion. Biopsy to be centered over the tumor to mark it location.

2. In our country with infrastructure issues, FNAC is acceptable provided multiple passes are done & quality smears are prepared. On site evaluation with rapid Diff Quick Stain ensures reducing number of non diagnostic FNAC’s.

3. For papillary tumors and intraductal carcinoma, excision biopsy for definite diagnosis.

4. Incision/Excision Biopsy: If high clinical suspicion and repeated FNAC or core biopsies are negative.

5. Frozen section is useful in expert centres if all above fail. Not recommended for papillary lesions & complex sclerosing lesions.


Based on detailed history and clinical examination, in women without any associated breast lump or abnormal mammogram, further evaluation is based on the colour of the nipple discharge as described below:

A) Galactorrhoea/White: If the woman is not lactating or pregnant then serum prolactin and thyroid profile should be done and reassessed

B) Grumous/Greenish: Consider a course of antibiotics if the nipple discharge is not blood stained and negative for RBC, especially if it is associated with inflammation. Should be reassessed.

C) Serous/Yellow/Blood-stained: Perform breast imaging with mammography and or USG

1. Single duct involved: For spontaneous, profuse, blood stained discharge or presence of RBC on cytology, consider excision of the duct (Microdochectomy)

2. Multiple ducts involved: For profuse multiple duct involvement especially in postmenopausal women, consider Hadfield’s surgery.

You can read the full guidelines by clicking on this link.

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